FDA approves Sanofi’s Wayrilz as BTK inhibitor for immune thrombocytopenia

The U.S. Food and Drug Administration has approved Wayrilz for adults with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA 3 phase 3 study, in which Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms. “The burden of immune thrombocytopenia can be both physical and emotional with significant overlooked symptoms that can impact various aspects of daily living,” said Caroline Kruse, President and CEO at the Platelet Disorder Support Association. “We are pleased to have a new treatment option that can help ease the ongoing strain of managing the disease for patients and their families.” As a novel oral, reversible, Bruton’s tyrosine kinase inhibitor, Wayrilz can help address the root causes of ITP through multi-immune modulation, targeting different pathways across the immune system, the company said.